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Optimization of NULOJIX® (Belatacept) Usage As A Means of Avoiding Calcineurin Inhibitor (CNI) and Steroids in Renal Transplantation

Information source: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Kidney Transplantation

Intervention: Alemtuzumab induction (Drug); MMF (Drug); Basiliximab induction (Biological); Short-term (3 months) Tacrolimus (Drug); Tacrolimus (Drug); Belatacept (Biological)

Phase: Phase 2

Status: Suspended

Sponsored by: National Institute of Allergy and Infectious Diseases (NIAID)

Official(s) and/or principal investigator(s):
Ken Newell, MD, PhD, Study Chair, Affiliation: Emory University
Christian Larsen, MD, DPhil, Principal Investigator, Affiliation: Emory University

Summary

Dialysis or kidney transplant are the two ways to treat kidney failure. Transplant recipients have to take anti-rejection medications to prevent their immune system (the body's natural defense system against illness) from rejecting their new kidney. Most patients who undergo a kidney transplant must take these anti-rejection medications for the rest of their lives. Taking standard anti-rejection medications for a long time can cause serious side effects, including kidney damage. There would be a benefit to finding new anti-rejection medications that work just as well, but don't damage the kidney. The purpose of this study is to find out if a new drug, NULOJIX® (belatacept), will minimize serious long term side effects seen with anti-rejection medications while still protecting the new kidney from damage. The researchers also want to learn more about the safety of this treatment and long term health of the transplanted kidney. Due to safety and availability of campath (alemtuzumab), enrollment of new subjects in this trial is suspended, and subjects currently enrolled will be followed on a reduced follow-up schedule.

Clinical Details

Official title: Optimization of NULOJIX (Belatacept) Usage As A Means of Avoiding CNI and Steroids in Renal Transplantation (CTOT-10)

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: The incidence of all adverse events (AEs) and serious adverse events (SAEs)

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Male or Female, 18-65 years of age at the time of enrollment;

- Ability to understand and provide written informed consent;

- Candidate for primary renal allograft from either a living or deceased-donor;

- No known contraindications to study therapy using NULOJIX® (belatacept);

- Female participants of childbearing potential must have a negative pregnancy test

upon study entry;

- Female and male participants with reproductive potential must agree to use FDA

approved methods of birth control during participation in the study and for 4 months following completion of the study;

- Flow-based PRA within last 12 months (in absence of a sensitizing event) of < 30% as

determined by each participating study center. If the subject experienced a sensitizing event after the PRA test date, then the PRA must be repeated and confirmed <30%;

- Negative crossmatch or a PRA of 0% on historic and admission sera as determined by

each participating study center.

- A documented negative TB test within the 12 months prior to transplant. If

documentation is not present at the time of transplantation, and the subject does not have any risk factors for TB, a TB-specific interferon gamma release assay (IGRA) may be performed. Exclusion Criteria:

- Need for multi-organ transplant;

- Recipient of previous organ transplant;

- EBV sero-negative (or unknown) recipients;

- Active infection including hepatitis B, hepatitis C, or HIV;

- Individuals who have required treatment with prednisone or other immunosuppressive

drugs within 1 year prior to transplant;

- Individuals undergoing transplant using organs from ECD or DCD donors;

- HLA identical living donors;

- Individuals at significant risk of early recurrence of the primary renal disease

including FSGS and MPGN type 2 or any other disease that in the opinion of the investigator is at increased likelihood of recurrence and which may result in rapid decline in renal function;

- Individuals previously treated with NULOJIX® (belatacept);

- Any condition that, in the opinion of the investigator, would interfere with the

participant's ability to comply with study requirements;

- Use of investigational drugs within 4 weeks of enrollment;

- Known hypersensitivity to mycophenolate mofetil (MMF)or any of the drug's components;

- Administration of live attenuated vaccine(s) within 8 weeks of enrollment.

Locations and Contacts

University of Alabama, Birmingham, Alabama 35294, United States

University of California San Francisco, San Francisco, California 94143, United States

Emory University, Atlanta, Georgia 30322, United States

Additional Information

Starting date: September 2011
Last updated: November 1, 2013

Page last updated: August 23, 2015

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